Effects of Recruitment Manouever on Oxygenation, Oxygen Reserve Index and Postoperative Pulmonary Complications

Sponsor
Balikesir University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05705245
Collaborator
(none)
80
1
29.3
2.7

Study Details

Study Description

Brief Summary

General anesthesia and mechanical ventilation decrease pulmonar volume; attenuate small airway closure, atelectasis, and increase the rate of hypoxia and postoperative pulmonary complications. Lung volume in obese patients decreases inversely with the increase in body mass index. Obesity is associated with increased atelectasis, hypoxia and postoperative pulmonary complication rates during anesthesia . Alveolar recruitment maneuver is a technique where high positive end-expiratory pressure (PEEP) is applied for for short periods, follwed by a continuous PEEP appşication throughout surgery. This has become a standard practice during anesthesia in recent years. Oxygen reserve index (ORi) is an index measured with a non-invasive finger-tip sensor and shows the oxygen content of the venous blood. It is effective at high oxygen levels and may indicate the presence of hyperoxia. Our aim is to examine the effect of alveolar recruitment maneuver on oxygenation parameters under anesthesia and the correlation with ORi in morbidly obese patients.

Condition or Disease Intervention/Treatment Phase
  • Other: recruitment

Detailed Description

Patients with body mass index> 40 m2, scheduled for bariatric surgery under general anesthesia will be monitorised with the ORi sensor and monitored at regular intervals. Preoperative and postoperative lung aeration will be evaluated with lung ultrasaund. İntraoperative standart anesthesia will be administered by an anesthesiolıgist not aware of the ultrasound. Alveolar recruitment will be applied by the same anesthesiologist if necessary. Blood gas samples obtained throughout surgery will be evaluated. ORİ values and intraoperative vital, respiratory, neuromuscular monitoring parameters will be obtained. Postoperative pulmonary complicationsa will be evaluated at postoperative day 5.

Finding will be compared between patients who received recruitment and who did not.

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Alveolar Recruitment Maneuver on Perioperative Oxygenation, Oxygen Reserve Index (ORi) and Postoperative Pulmonary Complications in Morbid Obese Patients Undergoing Laparoscopic Bariatric Surgery
Actual Study Start Date :
Jan 22, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
recruitment

Patients who received alveolar recruitment manouever during bariatric surgery

Other: recruitment
Automated alveolar recruitment menouever applied during mechanical ventilation in the intraoperative period

non recruitment

patients who did not receive alveolar recruitment manoeuver during bariatric surgery

Outcome Measures

Primary Outcome Measures

  1. postoperative pulmonary complications [5 days]

    Coughing, dyspnoe, side pain, phlegm

Secondary Outcome Measures

  1. Effect of recruitment manoeuver on oxygene reserve index [intraoperative]

    oxygene reserve index measured through a digital probe

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Inclusion Criteria:

Bariatric surgery general anesthesia and mechanical ventilation via orotracheal entubation Age between 18-65 ASA I-III BMI > 40 m-2

Exclusion Criteria:

Previous history of thorasic surgery, pneumothorax Chemo or Radiotherapy to the chest within 2 months History of Respiratory disease (COPD, emphysema, pneumonia, lung malignancy, Lung Bulla ) Emergency surgery Cardiovascular, renal, hepatic, neuromuscular disease İntracrabial pathology or trauma High intraoptic pressure Pulmonary Hypertension Pregnancy Criticall illness, or history of mechanical ventilation within 1 month

Contacts and Locations

Locations

Site City State Country Postal Code
1 Balikesir University Hospital Balikesir Turkey 10145

Sponsors and Collaborators

  • Balikesir University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
hafize fisun demir, assistant professor, Balikesir University
ClinicalTrials.gov Identifier:
NCT05705245
Other Study ID Numbers:
  • 2021/138
First Posted:
Jan 30, 2023
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by hafize fisun demir, assistant professor, Balikesir University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2023